Study of XIAP Antisense for Advanced Cancers

Advanced Cancer Clinical Trial

Official title:

A Phase I Trial of AEG35156 Administered by 2-Hour Intravenous Infusion in Patients With Advanced Cancers

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00385775
• Other study ID #: AEG35156-104
• Status: Terminated
• Phase: Phase 1
• First received: October 6, 2006
• Last updated: August 20, 2008
• Start date: June 2006
• Est. completion date: November 2008

Study information

• Verified date: August 2008
• Source: Aegera Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

This study is designed to find the maximum tolerated dose, safety and toxicity profile, and to identify any dose limiting toxicities of AEG35156 administered in 2-hour infusions to patients with advanced cancers.

Description:

This is a Phase I study, single-arm, open-label, dose escalation study to establish the recommended dose and activity of AEG35156 administered as a 2-hour daily infusion over 3 days initially followed by weekly 2-hour intravenous infusions in patients with advanced cancers. Subjects eligible for study entry must have proven advanced or metastatic cancer refactory to conventional treatment or for which no conventional therapy exists. The starting dose will be a fixed dose of 60 mg/day with escalation by steps of 50 to 100% in successive cohorts. Approximately of 30 patients will be entered in the study to determine the maximum tolerated dose.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: November 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• histologically proven diagnosis of advanced or metastatic cancer (including solid tumours and lymphoma)

• refractory to conventional treatment, or for which no conventional therapy exists with life expectancy of at least 12 weeks

• ECOG performance status of 0 or 1

• hematological and biochemical indices as specified within one week prior to treatment

Exclusion Criteria:

• known bleeding diathesis or concurrent treatment with anticoagulants

• primary brain tumours or brain metastases

• radiotherapy (except palliative), endocrine therapy, immunotherapy or chemotherapy during the previous four weeks (six weeks for nitrosoureas and mitomycin-C)

• all toxic manifestations of previous treatment must have resolved (excepting alopecia or certain Grade 1 toxicities)

• pregnant or lactating women

• major thoracic and/or abdominal surgery in the preceding 4 weeks

• high medical risks from non-malignant systemic disease including uncontrolled infection

• hepatitis B, C or Human Immunodeficiency Virus

• allergic history to antisense agents

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms

Intervention

Drug:
• AEG35156
weekly IV solution infused over 2 hrs

Locations

Country	Name	City	State
United Kingdom	Christie Hospital NHS Trust	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Aegera Therapeutics

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose level at which AEG35156 is well tolerated based upon development of toxicities during the first cycle of therapy unless delayed or cumulative toxicity is encountered. Assessments done weekly.		1 year	Yes
Secondary	Determine the impact of AEG35156 on inhibition and apoptosis in tumour biopsies or circulating tumour cells.		1 year	No
Secondary	Determine the occurence of XIAP knockdown in peripheral blood mononuclear cells.		1 year	No
Secondary	Determine the plasma pharmacokinetic profile of AEG35156.		1 year	No
Secondary	Determine the possible anti-tumour activity of XIAP.		1 year	No